Grant: Operating Grant: SPOR Innovative Clinical Trial Multi-Year Grant

Clinical trials use real patients under carefully controlled situations to measure how well a medication works and how safe it is. Knowledge gained from trials helps doctors choose which medicines to prescribe. Clinical trials for children are difficult to do, because they get sick less often than adults, and parents are understandably protective and reluctant to enroll their kids in a trial. Also, many hospitals need to be involved to study enough patients, which is expensive to coordinate. As a result, doctors don't have enough solid evidence for prescribing medicines to kids, which means a lot of guesswork. We are using new methods of study design to see if they will make clinical trials in children easier and better. We will create resources for trial design, management and analysis that can be used by researchers across Canada to make clinical trials for children easier, less expensive and more informative. These resources will be known as KIDSCAN, a Canadian effort for safe drugs in kids. We will be testing these new methods and resources in 4 clinical trials conducted in 6 pediatric emergency departments across 4 provinces. The medical conditions and treatments to test were chosen by researchers in pediatric emergency medicine because they are common, and include breathing problems, stomach upset, and pain from an injury or procedure. We will use statistical methods that will determine what information already exists that a trial can build on, and what information we might still need in order to change what doctors decide to do. As well, we will use centralized systems and services to conduct the trials and manage the data. To determine if these new methods and resources were successful we will look at the cost of the trial, the quality of the evidence generated, and the changes in procedures used in the pediatric ED. We hope to show that these new methods and resources will mean doctors will have more and better information on which to base their decisions.